CorMedix Presents Neutrolin® Post Marketing Surveillance Data at European ... - PR Newswire (press release)
BEDMINSTER, N.J., June 1, 2015 /PRNewswire/ -- CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases, today announced a presentation on Neutrolin® post marketing surveillance data at the 52nd European Dialysis and Transplant Association (ERA-EDTA) Congress. The Neutrolin Usage Monitoring Program is a post-approval surveillance program monitoring the routine use of Neutrolin, a novel catheter lock solution, in hemodialysis patients with tunneled central venous catheters (CVC). The program measures the number of catheter related blood stream infections (CRBSI), and the number of pre-mature CVC removals due to infection and/ or thrombosis. The secondary outcome measure was biofilm formation in CVCs. Other outcome measures included economic effects derived from using Neutrolin and effectiveness in the high risk groups (e.g. diabetic patients).
The poster, titled Neutrolin, A Catheter Lock Solution (CLS) with No Reported Human Resistance, Significantly Reduces the Rates of Infection and Thrombosis in Hemodialysis Patients Enrolled in a Post-Approval Surveillance Study, was presented on May 30, 2015. In 120 patients, the results to-date include three infections and two thromboses in 21,151 hemodialysis catheter-days. The Neutrolin Usage Monitoring Program results can be calculated as 0.14 infections per 1,000 catheter days (versus benchmark of 3.5 per 1,000 catheter days), a 96% reduction in infection rate, and 0.09 thrombosis per 1,000 catheter days (versus benchmark 2-3 per 1,000 catheter days), a 96% reduction in the rate of thrombosis.
"This surveillance data continues to be very encouraging," said Randy Milby, Chief Executive Officer, CorMedix. "We look forward to continuing to analyze the additional patient data in this effort to develop the optimum catheter lock solution, and address a critical medical need in the hemodialysis, oncology, and intensive care communities."
Neutrolin is a novel formulation of taurolidine, citrate and heparin 1000 units/ml that provides a combination preventative solution, decreases the triple threat of infection, thrombosis and biofilm to keep catheters operating safely and efficiently by optimizing catheter blood flow while minimizing infections and biofilm formation for oncology, hemodialysis, and intensive care patients. Neutrolin has CE mark approval for use in the European Union and was recently approved to enter a Phase 3 program in the United States. The U.S. Food and Drug Administration (FDA) has designated Neutrolin as a Qualified Infectious Disease Product (QIDP), which provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity under Hatch-Waxman patent exclusivity.
About CorMedix Inc.
CorMedix Inc. is a commercial-stage biopharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Europe is Neutrolin®, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients, in addition to oncology patients, critical care patients, and patients receiving total parenteral nutrition, IV hydration, and/or IV medications. Plans are in progress to expand commercial distribution into the United States, Asia, the Middle East, South America and Africa upon appropriate regulatory approval. For more information, visit www.cormedix.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans should be considered forward-looking. Risks applicable to CorMedix include the results of our studies and clinical trials, including the Neutrolin Usage Monitoring Program and are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Learn Why Steve Cohen's Point72 Asset Management Just Opened Huge ... - OctaFinance.com
Steve Cohen’s Point72 Asset Management New Position in NxStage Medical, Inc. (NASDAQ:NXTM)
Point72 Asset Management has filled a SC 13G form regarding Nxstage Medical, Inc 16.02 -0.19 -1.17%. Filing Link: 000089914015000460. Per Steve Cohen’s Point72 Asset Management’s filing, the filler now owns 5% of the Health Care-company, holding 3,163,744 shares.
NxStage Medical, Inc. (NASDAQ:NXTM) is a newly disclosed equity position for the hedge fund and the filing was required due to activity on May 29, 2015. This most probably shows Steve Cohen’s Point72 Asset Management’s confidence and optimism in the future of the company.
The hedge fund has been active in the Finance sector recently. In the fund’s latest 13F, it revealed several positions. This sector is 23% of Steve Cohen’s Point72 Asset Management’s US equities portfolio.
Nxstage Medical, Inc Hedge Funds Ownership
Latest SEC filings show 116 hedge funds and institutional investors own Nxstage Medical, Inc. The institutional ownership of the company in Q1 2015 is high, at 92.03% of the shares outstanding. They increased by 2370379 the total shares they hold. As of that quarter these institutional investors owned 58172942 shares. A total of 12 funds opened new positions in Nxstage Medical, Inc and 49 increased their holdings. There were 9 funds that closed their positions and 35 that reduced them.
7 investors have the firm in their Top 10. Some of these are: Cortina Asset Management Llc, Dafna Capital Management Llc, Oracle Investment Management Inc, Deerfield Management Co, First Light Asset Management Llc, Tamarack Capital Management Llc, Broadview Advisors Llc..
Altrinsic Global Advisors Llc is the most positive institutional investor on Nxstage Medical, Inc, with ownership of 666300 shares as of Q1 2015 for 0.25% of the fund’s portfolio. Cortina Asset Management Llc is another positive player owning 2155427 shares of the company or 1.61% of their stocks portfolio. CA Dafna Capital Management Llc have 4.87% of their stock portfolio invested in the stock for 366554. Further, Oracle Investment Management Inc disclosed it had purchased a stake worth 8.24% of the fund’s stock portfolio in the company. The NY Deerfield Management Company was also a notable investor in the firm, owning 5073050 shares. Nxstage Medical, Inc is 2.84% of the fund’s stock portfolio.
Company Profile
NxStage Medical, Inc. (NxStage)is a medical device company that develops, manufactures and markets products for the treatment of kidney failure, fluid overload and related blood treatments and procedures. The Company’s primary product is the NxStage System One (System One). It also sells needles and blood tubing sets primarily to dialysis clinics for the treatment of end-stage renal disease (ESRD). The Company operates in two segments: System One and In-Center. It distributes its products in three markets: home, critical care and in-center. In the System One segment it sells and rents the System One, PureFlow SL equipment and disposable products in the home and critical care markets. In the In-Center segment, it sells of blood tubing sets and needles for hemodialysis at dialysis centers and needles for apheresis. The Company’s products include the NxStage System One, Streamline Blood Tubing Sets and AV Fistula and Apheresis Needles.
Form 13G is used when the filer owns between 5% and 20% of the company and plans to hold it only as a passive investor. If the filler intend to exert control and if the stake’s size exceeds 20%, then a 13D must be filed. Therefore, activist investors and practices such as: hostile takeovers, company breakups, and other “change of control” events, are not permitted by 13G filers.
The essence of quality healthcare doesn’t only lie in curative treatment but also in the restoration of quality of life during and after treatment. Severe kidney failure, referred to as End Stage Renal Disease, or ESRD, and one of its treatment modalities, dialysis, are traditionally believed to have dire consequences. Many people shudder at the very thought of it.
However, with recent developments in the healthcare industry, therapy for ESRD in the form of dialysis promises quality of life.ESRD (where less than 10 per cent of the kidney functions as compared to normal) is a devastating illness for the vast majority of patients. The treatment options available are kidney transplantation wherever possible (the best option in most cases) and dialysis in others. There are two forms of dialysis: haemodialysis (cleansing one’s blood using artificial kidneys or filters) and peritoneal dialysis (done by infusing clean fluid into the abdomen by implanting permanent catheters in the abdomen and using the peritoneal membrane to clean the waste products).
There are close to 200,000 people developing ESRD every year in India and more than 95 per cent of them die for lack of treatment. Less than 5,000 transplants are done a year and the remaining cases go for dialysis. In general there is a feeling that life on dialysis is miserable and morbidity and mortality levels are high with a very low rate of long-term survival. Hence in India many people feel dialysis is a death knell. However, this has changed significantly over the last decade or so, thanks to high-quality water purification systems; better management of patients, especially their nutrition, anaemia and bone metabolism; and better-quality, high-flux biocompatible membranes, and so on. It is not uncommon now to have long productive life-spans on dialysis. Here is the amazing story of a dynamic dental surgeon who has led a full life in spite of ESRD for over a decade.
K.H. Sudheer developed ESRD in 2003, for which he underwent a kidney transplant, his father being the donor. However, the transplant failed in 2008 and he has been on dialysis since then, three to four times a week. Undeterred, Dr. Sudheer continues to lead an active life and has had a baby. He works 14 hours a day when not on dialysis, has opened a chain of dental clinics, participates and speaks at important academic conferences, is a wonderful husband and a doting father. He makes it a point to exercise regularly and is an avid swimmer.
This truly is an amazing story of how he has battled and conquered his illness while being on dialysis. He should be an inspiration and role model for all kidney patients. This highlights the fact that there is an immense possibility of a good life even on dialysis if we choose to have it. Kidney disease is a major problem in India. The endeavour should be to prevent it before it happens, control it by conservative measures in the early stage and not to despair in the late stages as there is a full life on dialysis or transplantation even at this stage. Dr. Ballal is Director of the Manipal Institute of Nephrology and Urology
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Kidney dialysis patient leaves St. John's to bike across Canada - CBC.ca
Dale Calibaba left St. John's Monday on a cross-Canada trip to show the ways people without functioning kidneys can go about living normal lives.
Calibaba, 46, has been going through kidney dialysis treatment for over a decade. For years, he had to go to a clinic three times per week to get his treatment.
Dale Calibaba left St. John's on Monday to start a bicycle trip across Canada, raising awareness around kidney dialysis treatments. (CBC)
Eventually he was given a 'peritoneal dialysis' (PD) machine, which frees him from those regular visits — and allows him to do things like cycling across the country.
PD allows patients to give themselves dialysis treatments at home or on the road rather than having to regularly go to a health care centre.
For Calibaba, getting his own PD machine means he can now take on such an ambitious project.
"It's been a long road," he told supporters on the steps of St. John's City Hall Monday morning.
"One of the reasons why I am riding across Canada is to promote the types of PD options that patients can have, other than having to go to a clinic and hook up to a human dialysis machine three times a week."
Living a life-long dream
In the moments before he set off on his bike in downtown St. John's, he told the crowd he hopes to to empower other patients to educate themselves about treatment options.
Calibaba spoke to supporters on the steps of St. John's City Hall on Monday. (CBC)
He believes that peritoneal dialysis has not only allowed him to live a normal life, but to live out his life-long dream.
After leaving St. John's on Monday, Calibaba plans to cover about 120 km per day with his dialysis machine in tow the whole way.
"I'm very excited," he said.
"I'm just anxious to get on the beginning of the Trans-Canada Highway and start heading back west."
Cleaning chemical accidentally released into dialysis water at Canadian hospital - NephrologyNews.com
Four dialysis patients in Edmonton, Alberta, Canada, are stable after a cleaning chemical was accidentally released into the water supply May 29 at Royal Alexandra Hospital. A valve was accidentally turned on during regular system cleaning, a spokesperson told the Edmonton Journal. The hospital did not disclose what chemical was used, but Curtis Johnston, facility medical director at the Royal Alexandra Hospital told Global News Canada that the chemical would cause breathing problems within the first few hours of exposure.
"We don’t think there will be any long-term affects from this,” he said.